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Exploratory study of imiquimod topical therapy for Bowen's disease

Exploratory study of imiquimod topical therapy for Bowen's disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230132
Enrollment
12
Registered
2024-02-01
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowen disease

Interventions

Patients with Bowen's disease will be treated with imiquimod 5% applied to the target site 3 times a week before bedtime. Three courses of 3 weekly applications will be repeated for 4 weeks, followed

Sponsors

Yoshikawa Shusuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histopathologically diagnosed Bowen's disease on biopsy (2) Tumor lesion size of 10 mm or greater on the trunk and extremities, excluding lesions on the head and neck, fingernail area, external genitalia, and perianal area. (3) Obvious neoplastic lesion on pre-registration CT. (4) Over 18 years old (5) Written consent to participate in the study has been obtained from the patient (6) ECOG PS 0-2

Exclusion criteria

Exclusion criteria: (1) Previous topical treatment, cryotherapy, radiation therapy, or post-surgical treatment for Bowen's disease (2) Multiple Bowen lesions (3) Strong inflammatory findings (4) Systemic infection (5) Difficulty in performing topical treatment as prescribed (6) Psychiatric illness or psychiatric symptoms that interfere with daily life (7) On continuous administration of steroids or other immunosuppressive drugs (8) Patients with a history of hypersensitivity to imiquimod (9) Patients who are judged to be inappropriate for this study by the treating physician.

Design outcomes

Primary

MeasureTime frame
Tumor shrinkage rate at the end of protocol treatment

Secondary

MeasureTime frame
Lesion disappearance rate at the end of protocol treatment Local recurrence rate 6 months after completion of protocol treatment Adverse event rate (local skin reaction) up to 6 months after completion of protocol treatment

Contacts

Public ContactShusuke Yoshikawa

Shizuoka Cancer Center

s.yoshikawa@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026